UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019137 |
|---|---|
| Receipt number | R000022124 |
| Scientific Title | Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY- |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2018/05/07 16:39:51 |
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Basic information
Public title
Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-
Acronym
Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-
Scientific Title
Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-
Scientific Title:Acronym
Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To do additional research on safety and efficacy of 88 patients enrolled in JUST-study, for further discussion of bi-weekly eribulin therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Time to Treatment Failure(TTF) of bi-weekly patients
Key secondary outcomes
Overall survival(OS), safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
All who enrolled in JUST-STUDY
Key exclusion criteria
none
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Ohtani |
Organization
Hiroshima City Hospital
Division name
Breast Surgery
Zip code
Address
7-33, Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken
TEL
082-22102291
eriburlin-study@npo-acro.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | JUST-STUDY Executive Office |
Organization
NPO Advanced Clinical Reserch Organization
Division name
JUST-STUDY Executive Office
Zip code
Address
2-10-3,kotobukicho,Fuchu,Tokyo
TEL
042-352-7676
Homepage URL
eriburlin-study@npo-acro.jp
Sponsor or person
Institute
NPO Advanced Clinical Reserch Organization
Institute
Department
Personal name
Funding Source
Organization
NPO Advanced Clinical Reserch Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a
Management information
Registered date
| 2015 | Year | 09 | Month | 28 | Day |
Last modified on
| 2018 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022124
